Tooth positioner and vibrator combination

ABSTRACT

A tooth positioner is combined with a vibrational source, thus speeding orthodontic remodeling.

PRIOR RELATED APPLICATIONS

This application claims priority to U.S. Ser. No. 61/615,480, filed Mar.26, 2012, and incorporated herein by reference in its entirety.

FEDERALLY SPONSORED RESEARCH STATEMENT

Not applicable.

REFERENCE TO MICROFICHE APPENDIX

Not applicable.

FIELD OF THE DISCLOSURE

This disclosure relates to vibrating devices for use in orthodonticremodeling.

BACKGROUND OF THE DISCLOSURE

Orthodontics is the dental specialty that treats malocclusion throughthe movement of teeth as well as control and modification of facialgrowth. Malocclusion is a problem in the way the upper and lower teethfit together in biting or chewing—the word literally meaning “bad bite.”The condition may also be referred to as an irregular bite, crossbite,or overbite. Malocclusion may be seen as crooked, crowded, or protrudingteeth. It may affect a person's appearance, speech, and/or ability toeat.

Correcting malocclusions is usually accomplished by using a continuousmechanical force to induce bone remodeling, thereby enabling the teethto move to a better position. In this approach, orthodontic appliancesprovide a continuous static force to the teeth via an archwire connectedto brackets affixed to each tooth or via a removable appliance such asan aligner that fits over the dentition. As the teeth slowly move due tothe force, the force is dissipated. The archwires or retainer areadjusted to add additional force and to continue the desired toothmovement. Although effective, this widely accepted approach takes anaverage of two years to complete.

Dental researchers have long postulated that a pulsating or otherwisenon-static force might also be used to move teeth more rapidly and toease the discomfort of traditional orthodontics. However, Mao wasprobably the first to prove that the use of cyclic forces could improvedental straightening in rabbits (see U.S. Pat. No. 6,684,639, U.S. Pat.No. 6,832,912, U.S. Pat. No. 7,029,276). Certain dynamic loadingpatterns (cycling force with rest periods) were shown by Mao to greatlyincrease bone formation compared to static loading. Inserting restperiods is now known to be especially efficacious as it allowsmechano-sensitivity to be restored to the bone tissue. A point ofdiminishing returns is reached within each loading session. Therefore, acyclic force can increase the rate of bone formation significantly.

U.S. Pat. No. 4,244,688, U.S. Pat. No. 4,348,177, and U.S. Pat. No.4,382,780 describe devices used to vibrate the teeth during orthodontictreatment, although each uses a different means of applying a vibration.U.S. Pat. No. 4,244,688 employs a cumbersome external power source topower one to four small motors, whereas U.S. Pat. No. 4,348,177 usespulsating fluids moved with the chewing motion of the jaw, and U.S. Pat.No. 4,382,780 uses a radio and speaker to set up a vibration. Thesedevices are mounted on a bulky headgear that surrounds the head and areconnected directly to the teeth by its intraoral portions. The devicesare cumbersome, difficult to construct, expensive, and are difficult anduncomfortable to use, thus reducing patient compliance.

U.S. Pat. No. 5,030,098 by Branford describes a hand-held device thatsimulates chewing in order to treat periodontal disease by increasingblood flow to the gums. The mouthpiece has a perforated malleable platesuch that biting of the mouthpiece results in the plate adapting to theuser's bite, which varies with each user. The external vibrator impartsmotion to the mouthpiece and thus the user's teeth. The device, however,uses an external power source and vibrator. Further, the dental plate isbrass, and is very unpleasant to bite on.

U.S. Pat. No. 5,967,784 by Powers describes a similar device to thatdescribed by Branford. It too is a hand-held tooth vibrator that issimple and has an exterior motor inside a housing that is connected to avibrating mouthpiece portion for gripping between the teeth of thepatient. The vibration is believed to alleviate discomfort by increasingblood flow.

The devices of Branford and Powers seem superficially similar to thosedescribed herein. However, there is no recognition in either patent thatthe vibratory device can be used for alveolar bone remodeling or morerapid tooth movement. Furthermore, the shape of the dental plate in eachcase is a very flat U- or Y-shaped member that is less effective forremodeling dentoalveolar bone. Additionally, the vibration is notoptimized in frequency and amplitude for remodeling. All of theseshortcomings reduce the effectiveness of these devices for craniofacialremodeling uses.

U.S. Pat. No. 6,632,088 describes a bracket with powered actuatormounted thereto to provide vibration, but this device is cumbersome, andthus may affect patient comfort and ultimately patient acceptance of thedevice. Further, the device locks to the bracket and archwire, andvibration of the tooth through the bracket is less than optimal, causingwear to the tooth enamel and causing discomfort.

WO2007116654 describes another intra-oral vibrating mouthpiece, but themouthpiece is complex, designed to fit over the teeth and will beexpensive to manufacture. Further, to the extent that this devicevibrates the brackets, it suffers from the same disadvantages above.

US2008227046, owned by OrthoAccel, describes both intra-oral andextra-oral dental vibrators with processors to capture and transmitpatient usage information. The bite plate in this application asspecially designed to contact occlusal as well as lingual and/or buccalsurfaces of the dentition, and thus is more effective than the prior artdevices in conveying vibrational forces to the teeth. Further, thedevice has actually been tested in clinical trials and has been shown tospeed orthodontic remodeling as much as 50%. Finally, the device isslim, capable of hands free operation, and optimized for force andfrequency. Thus, its comfort level and compliance was also found to behigh, with patients reporting that they liked the device. In fact, thisdevice has been marketed as AcceleDent® in the United States, Canada,Australia, the United Kingdom and various other counties and hasachieved remarkable commercial success since its introduction.AcceleDent® represents the first successful clinical approach toaccelerate orthodontic tooth movement by modulating bone biology in anon-invasive and non-pharmacological manner. US2010055634, also byOrthoAccel, describes second generation vibrating dental devices with animproved bite plate, quieter and less variable motor, and furtherbeneficial features.

Goals in orthodontics include the production of an ideal occlusion andbeautiful smile in a timely manner for all patients. Unfortunately,these lofty aspirations are often not met, due to lack of patientcooperation (e.g., lack of elastic wear, poor oral hygiene, brokenappliances, etc.) or errors that accumulate in the treatment process.Such errors might include: radiographic and tracing errors, errors indiagnosis, in bracket/band placement, limits in manufacturing tolerancesof wires and brackets, inappropriate selection of mechanics, errors inmechanics, etc.

Consequently, a favorable orthodontic correction may be marred by a lackof detail in individual tooth positioning. The tooth positioner wasinvented in the forties by Dr. Kesling (see U.S. Pat. No. 3,407,500) toaddress such problems. The tooth positioner is a removable appliancethat can assist in fine-tuning orthodontic results and may produceswifter completion of treatment, especially when the occlusion is nearlyideal and additional changes in wires or brackets may introduce otherdilemmas or if the patient's interest and/or cooperation has run out.

There is considerable agreement that the tooth positioner is one of thefinest retention devices ever invented. See e.g., Paula Allen-Noble,John Fuller, Clinical Impressions 13(1): 24-26 (2004) (“There isprobably little argument that the positioner is the best finishingdevice invented.”). Long-term compliance, however, has been problematicbecause the positioner is perceived as bulky and unaesthetic, and manytherefore use the positioner as a finishing appliance, worn 24 hrs a day(except for eating and brushing) but for limited periods, e.g., about aweek, and thereafter worn at night.

The first positioners introduced in the early 60's were made of arubber-based material. As technology advanced, a variety of materialswere offered for their unique properties to produce a blend of applianceefficacy and patient comfort. Silicone became very acceptable because ofits aesthetic look (clear), resistance to heat and hypoallergenicproperties, but it was plagued with inaccuracy arising from thefabrication process, making it less effective in correctingmalocclusions.

Allesee Orthodontic Appliances, however, recently developed a new typeof silicone positioner, using a more resilient and flexible materialthat will not distort from its original shape and continues to deliverthe same force for an extended amount of time. This newly developedmaterial allows the positioner to be processed directly on thediagnostic wax setup mounted on a plaster-free articulator, whichpermits the technician to observe and control proper compression andcuring of the material, creating a more accurate positioner. Inaddition, a special coating is used to enhance the translucency. TheProFlex Positioner™ is slimmer, clearer and more resilient than pastsilicone positioners, making it more aesthetic and pleasing to patients,which encourages patient compliance.

U.S. Pat. No. 4,348,178 by Kurz describes a combined tooth positionerand vibrator. However, the vibration is provided by ultrasonic motor orhydraulic pump. Thus, the device is not optimized for tooth remodeling,having an incorrect frequency and force. Further, the device is held inplace by a set of straps that fit around the head, so as to hold thedevice firmly in place while sleeping. While the idea behind Kurz hasmerit, its execution is clumsy and the device completely detracts frompatient aesthetics and negates compliance efforts.

US2008227046 by OrthoAccel mentions that the vibratory device can beused with existing orthodontic devices, include the aligner known asInvisalign™. However, the device is not designed itself to be analigner, nor are the connectors specially designed for this use.

Therefore, although orthodontic remodeling has greatly progressed overthe decades, poor patient compliance continues to plague parents andorthodontists alike. All patients want and deserve to be comfortable aswell as attractive during treatment, and minimizing treatment time anddiscomfort are important tools in increasing compliance. Thus, what isneeded in the art are improved tools for speeding orthodontic remodelingand ensuring patient compliance with orthodontic treatments.

BRIEF SUMMARY OF THE DISCLOSURE

The invention more relates to a combination tooth positioner andvibrating dental device. Thus, the bite plates of e.g., US2008227046 andUS2010055634, are replaced with a tooth positioner, specially made foreach patient. The vibrator portion of the device speeds dentalremodeling by as much as 50% and the tooth positioner portion which iscustom crafted for each patient is widely recognized to be an excellentdevice for correcting malocclusion. The combination of the two, thusprovides advantages of speed, the best aesthetics, and the bestalignment tools, and thus encourages patient compliance and successfuloutcomes.

The tooth positioner can be made by any suitable methodology in the artor to be developed in the future. Suitable methods include thosedescribed in US20090068612, US2011236849, US2011039223, US2006223022 andthe like. Thus, the positioner is generally made from an impression of apatient's teeth, but with at least one tooth position reset for betteralignment. Thus, the positioner applies pressure to at least one of apatient's teeth, causing it to realign under the pressure, and therealignment process is accelerated by applying vibrational forces atleast one time per day.

In addition to a tooth positioner, the product can be combined with analigner. Aligners differ from tooth positioners mainly in the way thatthey are made and used, although the structure of the devices aresimilar. A tooth positioner is manually made with a casting whereinspecific tooth positions on the casting are adjusted before molding atooth position from the casting. Tooth positioners are also used as afinishing product for the final phase of treatment.

Aligners, by contrast, are custom made for each patient using a digitaltreatment plan wherein complex software predicts the movement of theteeth throughout treatment and several aligners for the entire course oftreatment are digitally designed. Of course, positioners can also bemade using digital technology, and this is becoming more common as labsand orthodontic offices are being equipped with 3D scanners and thelike.

Both products are shaped to fit the teeth, with one or more positionsbeing adjusted to apply pressure to one or more teeth. Therefore, forthe purposes of this invention, the tooth positioner can also bedigitally made in the manner of aligners, such as Invisalign.™

The vibrating portion of the dental device can be of any suitabledesign, including those described in US2008227046 and US2010055634, andpreferably includes a processor for capturing and transmitting usagedata, which provides an important tool for monitoring (and thusencouraging) patient compliance.

In order to combine the tooth positioner with a vibrational dentaldevice, the tooth positioner must be modified to have a connector thatoperably and reversibly couples the tooth positioner to the vibrator.The connector should be sufficiently rigid to convey vibration to theresilient material of the tooth positioner. Some force will bedissipated by the resilient material that the tooth position is made of,and thus not transmitted to the dentition, but this can be accommodatedby providing a slightly higher force.

The connector comprises two parts: 1) a plug or stem and 2) a socket orreceptacle into which the stem fits, preferably in a snap fit. In apreferred embodiment, the socket is on the tooth positioner and thevibrator has the stem. Thus, the patient can wear the positioner aloneat night, as well as use it with vibration 1 or more times per day, andthe patient will not be bothered by a small protruding stem during therest of the time the positioner is used without vibration.

In one embodiment, the stem has e.g., a cylindrical shaft for insertioninto the socket in the tooth positioner. The shaft has e.g., adepression or groove circumnavigating its circumference, into which acircular spring inside the socket will fit. The application of a smallamount of force stretches the spring slightly, allowing the device to beremoved. The connector can also be asymmetric, thus preventing the userfrom inserting the tooth positioner upside down, although of course thetooth positioner itself will be asymmetric, fitting the teeth on onlyone orientation.

This above is only one example of a snap fit, and any snap fit design orcam lock (insert and twist) or other connecting means can be used. Forexample, the shaft could be provided with spring fitted buttons thatsnap into depressions inside the socket, and press fit spring pins arecommercially available in a range of sizes. As another example, the stemcould be composed of two or more prongs that fit into the socket as acantilevered snap fit. As yet another example, the shaft can be squareor rectangular or asymmetrical, yet still be combined with a circularspring or spring pins as described. A ball and socket snap fit couldalso be used, but may not be preferred as allowing movement about theball joint.

Ideally, the socket is made of metal or a high durometer plastic (30-40Shore D), such as high impact polystyrene, and which communicatesvibrational forces from the extra-oral vibrating component to theintra-oral tooth positioner. The tooth positioner is thus formedover/around the socket.

The tooth positioner is custom made for each patient from a cast of thepatient's dentition, but with any poor alignment corrected, or made viaa digital treatment plan using e.g., an iOC, iTero, OrthoCad 3D orsimilar digital scanner. Preferably, the tooth positioner has a hardinner core fitted with a socket for being coupled to an externalvibratory device, but the body of the tooth positioner is e.g.,silicone, which fits over the hard inner core and touches every surfaceof the dentition, applying pressure to realign teeth as needed.Additional tooth positioners or aligners can be fabricated as treatmentproceeds and the teeth progress towards optimal alignment.

Any style of tooth positioner can be used, including hinged positioners,as described in U.S. Pat. No. 4,898,535 and shown in FIG. 8A, orseparate upper and lower positions, both allowing for oral access.However, since these designs require the use of vibration means for eacharch, the position is preferably a unitary positioner covering upper andlower arches with holes therein for airway management can be used, asshown in FIG. 8B. The aligners or positioners can also include the forcesurfaces described in US20110020761, and shown in 8C. These raised areasallow the aligner to exert additional forces, thus moving difficultteeth, e.g., a force positioner can be applied to “twist” a rotatedtooth into better alignment.

In other embodiments, an orthodontic remodeling device comprises a toothpositioner being U-shaped and contacting labial, lingual and occlusalsurfaces of a patient's dentition; said tooth positioner shaped to applya straightening force to at least one of said patient's teeth; saidtooth positioner being operably and reversably connected to a housingenclosing a power source operably connected to a vibratory source, saidvibratory source being able to vibrate at 20-40 Hz at a force of 0.1-2Newtons and thus vibrating said tooth positioner.

The housing can be extraoral or intraoral. The tooth positioner cancontact both upper and lower arches of said patients teeth, or separateupper and lower positioners can be provided for same, an upperpositioner contacting an upper arch of said patients teeth, and a lowerpositioner contacting a lower part of said patients teeth.

The postioner can be made with various materials, and if a particularlystiff material is used, can be coated with a biocompatible resilientpolymer, such as medical grade silicon. If the positioner is made of amore resilient material, it may be needed to provide a stiff inner core,at least at the socket, for adequately holding the connector or stem ofthe vibratory means. However, with many materials and/or smallerhousings, such will not be necessary.

Although medical grade silicone rubbers are preferred for the toothpositioner since they have good tranparency, strength, no taste and agood feel, it can be made from any suitable material, includingalginate, rubber, dimethylpolysiloxanes, vinyl, urethane, acrylic,polypropylenes, polyurethane, and the like. A preferred material is alow temperature vulcanizing (LTV) vinyl silicone rubber, a hightemperature vulcanizing (HTV) Japanese silicone (ORTHOCON™).

While the vibrating component can be positioned intra-orally, e.g.,inside the tooth positioner on the inner core, an extra-oral embodimentis preferred as not being size limited and thus being able to include aprocessor and e.g., USB or data port to capture and transmit usage data.Clinical studies have shown that the ability to monitor usage isimportant to maximize patient compliance.

However, when combined with an aligner such as the Invisalign, a smallintra-oral vibrator may be preferred for aesthetic reasons. Thus, eachof the upper and lower aligners is fitted with one or more sockets intowhich a small vibrator/battery can be removably inserted, and theposition of same is preferably on the lingual side where it cannot beseen. Alternatively, the vibrator can be permanently affixed thereto, ormagnetically affixed with two small high field strength magnets.

The extra-oral embodiment generally includes a housing containing avibratory source, power source and the wiring needed to operable connectand operate same. Preferably, the extra-oral embodiment also includes aprocessor to capture usage data and a data port or USB for communicatingsame, but such can be omitted, e.g., for smaller housings, especiallyfor intraoral vibrators. The processor can also control the vibrator andin some embodiments may allow for the user to select a range offrequencies and forces, within a suitably efficacious range. The housingalso includes a connector, for operably connecting to the toothpositioner, as already discussed above, and can include other componentssuch as a charging port, or battery access hatch, indicator lights, andthe like.

For patient comfort and aesthetics, the smallest and quietest means ofproviding vibration are employed. A large number of very small vibratingmotors are available, as shown in the table below, but piezoelectricmotors may be preferred due to the small size, and off-set weightedmotors may be preferred due to low cost. Particularly preferred are thesubstantially planar motors where the vibration is substantiallyparallel to the substrate (e.g., U.S. Pat. No. 5,554,971, U.S. Pat. No.5,780,958, US2009224616, US2008129130, US2007103016, WO0178217, eachincorporated by reference).

Company Catalog Size Specifications ELLIPTEC NA 10 × 3 × 2 mm 3-6 voltsAG ™ See U.S. piezoelectric motor Pat. No. 6,870,304 SURPLUS MF820 8 × 4mm 1.5 to 4.5 VDC TRADERS ™ (0.315 × weighted shaft 0.1575 inches)SURPLUS MF918 0.45 × 0.16 1 VDC to 5 VDC TRADERS ™ inches 18 ohmsWeighted shaft MOTOROLA ™ G13566 0.44 × 0.18 1 VDC to 9 VDC inches 10ohms Weighted shaft SURPLUS MF835 0.45 × 0.24 1.3 Vdc TRADERS ™ inches100 mA Weighted shaft MATSUSHITA ™ V0296A 0.24 inch 1.5 VDC diameterWeighted shaft SURPLUS ME235 0.24 × 0.5 1.5 to 3 VDC TRADERS ™ inches 62mA weighted shaft PRECISION 304-002 4 mm × 8 mm 2.3 VDC to 3.6 VDCMICRO- 100-120 mA DRIVES ™ 11000 rpm Weighted shaft PRECISION 308-1003.4 × 8 2 to 3.3 V, 120 mA MICRO- 12000 rpm DRIVES ™ 8 mm ShaftlessVibration Motor

In addition to electromagnetic motors and piezoelectric motors, othermotor types could be used including mechanical actuators, ultrasonicmotors and the like. Vibrations may be oscillating, random, directional,circular, and the like. Vibrators are well within the skill of the art,and several are described in the patent literature (and commerciallyavailable as seen above). For example, US2007299372, US2007255188,US2007208284, US2007179414, US2007161931, US2007161461, US2006287620,each incorporated by reference, describes various vibrator motors.

The cyclic forces or vibration applied to the tooth positioner is atfrequencies between 1 to 1000 Hz (preferably 10-100 Hz and mostpreferred 20-40 or 30 Hz) and a force of 0.01-5 Newtons (or 0.1-0.5 or0.2-0.3 or 0.25 Newtons) for a period of 1-60 minutes, preferably about1-30 or 1-10 minutes or 20 minutes. This is followed by a period ofrecovery, ranging from 2-24 hours, preferably from 4-12 hours, and thecycle is repeated until one or more teeth are successfully moved.

More particularly, the orthodontic appliance of the invention has avibrational source capable of providing a vibratory force at a frequencyof about 30 Hz and a force of about 0.25 Newtons. Excess force isgenerally unpleasant to the patient, especially force coupled with highfrequency, and in preferred embodiments these parameters are patientadjustable within clinically efficacious ranges. The force can bechanged to accommodate different materials, usually being reduced withstiffer materials and increased with softer materials.

In addition to capturing and storing usage data, the processor can alsocontrol the force and frequency parameters, and appropriate controls oruser interface can be provided form same.

Preferably, the vibrating component has a more stable vibrator withimproved performance characteristics of decreased sound and low variancefrequency and force. In particular, the improved vibrator has a noiselevel less than 55 dB when measured at 6 inches, a frequency at 20-40Hz, with a variance of only 2 Hz, and a force of 0.1-0.5 Newtons, with avariance of +−0.05 N.

Consistency of frequency and force is achieved e.g., via a feedback loopwhereby motor speed is monitored and software adjusts the motor asneeded. More particularly, the motor contains an integrated encoder thatprovides multiple high and low signal outputs per every motorrevolution. The software counts the time between every encoder event andcompares this to the desired target (e.g., 30 Hz). Based on thiscomparison, the software then adjusts the pulse width modulation that isdriving the motor to increase or decrease speed as appropriate tomaintain the desired speed. Accurate controlling of speed also controlsthe force.

A DC 6V Motor having off-set weight and 8 line integrated encoder isknown to provide these characteristics, but other vibrators may alsoprovide these performance characteristics, and can be easily tested forsame. Preferably the battery is a chargeable 100 mAh Li battery.Preferably, the motor is the Series 1506 DC Motor, by MicromoElectronics, Inc. (Part No. 1506N006SRIE2-8), and the battery is a 100mAh Li-PO battery by Harding Energy (Part no. BAN-E601421).

Batteries may drive the vibrational source for some intra-oralembodiments. Small coin batteries, alkaline or lithium, are preferreddue to their small size, but hydrogen batteries may also be preferreddue to their power and power density, particularly as size and costdecrease with further technological development. At this time,rechargeable batteries are preferred, and thus the housing can alsocontain an access port or charging port for same.

For certain embodiments, a battery that can be wirelessly recharged ispreferred for longer product life (e.g., US2009051312, U.S. Pat. No.7,511,454), but in other embodiments a low cost device is manufacturedthat is intended to be disposable. It is known in the art to select anappropriate power source/motor combination to provide a complementaryorthodontic force that vibrates within the frequency and power suitablefor orthodontic remodeling.

Another improvement on the extra-oral vibrating device is the provisionof a separate charging stand that serves to dock the vibrator and chargeit at the same time. The charging station also has a display andsoftware so that the user can see the usage data. Thus, a dentalprofessional (or parent) can determine whether the patient is using thedevice as intended. In one embodiment, the display shows the number ofuses per running 7 days (for example 6/7=86%), the number of uses perrunning 30 days (25/30=83%)) and the total number of uses (145 uses). AUSB port can provide the same functionality.

Any off the shelf on/off switches can be used. Particularly preferredfor the intraoral device is an on/off switch with depressible activator(push button or rocker). However, for the extra-oral vibratory deviceany off/on switch or rotating dial can be used.

The device of the invention can be used in a variety of oral andmaxillofacial applications including malocclusion, trauma repair,temporomandibular joint and muscle disorders (TMJDs), Lefort and otherskeletal facial fractures, craniofacial anomalies such as boney clefts,bone defects, dentofacial deformities, dental implants, periodontal bonegrafts as well as tooth, muscle, nerve, tendon, ligament, bone, andconnective tissue repair.

As used herein, “tooth positioner” means a custom made intra-oral biteplate that contacts occlusal, facial and lingual surfaces of the teeth,preferably both arches with a single bite plate, but wherein the imprintfor one or more teeth has been adjusted in position, so as apply acorrective pressure to one or more teeth and allowing orthodonticcorrection. The term is intended to include tooth positioners used onlyfor finishing, as well a total treatment aligners, and such. It does notinclude traditional archwire and brace orthodontics.

The use of the word “a” or “an” when used in conjunction with the term“comprising” in the claims or the specification means one or more thanone, unless the context dictates otherwise.

The term “about” means the stated value plus or minus the margin oferror of measurement or plus or minus 10% if no method of measurement isindicated.

The use of the term “or” in the claims is used to mean “and/or” unlessexplicitly indicated to refer to alternatives only or if thealternatives are mutually exclusive.

The terms “comprise”, “have”, “include” and “contain” (and theirvariants) are open-ended linking verbs and allow the addition of otherelements when used in a claim.

The phrase “consisting of” is closed, and excludes all additionalelements.

The phrase “consisting essentially of” excludes additional materialelements, but allows the inclusions of non-material elements that do notsubstantially change the nature of the invention.

ABBREVIATION EXPANSION LTV low temperature vulcanizing HTV hightemperature vulcanizing

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention and benefitsthereof may be acquired by referring to the following description takenin conjunction with the accompanying drawings in which:

FIG. 1A-B provide standard dental nomenclature for the dentitionsurfaces.

FIG. 2 is a perspective view of the extra-oral vibratory device andtooth positioner.

FIG. 3A-B include two transparent perspective views of the toothpositioner with socket.

FIG. 4 is a cross-sectional view of a half of a tooth positioner,illustrating an exemplary socket in further detail. Also shown is aschematic of the extraoral vibrator with stem that fits into the socket.

FIG. 5 shows a cross-sectional view of a half of a tooth positioner,illustrating an exemplary socket with a different snap fit.

FIG. 6 shows a cross-sectional view of a half of a tooth positioner,illustrating an exemplary socket with a different snap fit.

FIG. 7A shows an aligner and teeth. FIG. 7B shows a close up of onetooth having a socket into which a vibrator can fit (vibrator not drawnto scale). FIG. 7C shows a close up of a vibrator with stem.

FIG. 8A-C show prior art positioner styles, including a hinged positionin 8A, and a traditional positioner with holes for airway management in8B. FIG. 8C functions to allow force to be applied to correspondingraised surfaces that are adhered to teeth. Any of these positionerstyles can be combined with vibratory means, as described herein.

DETAILED DESCRIPTION

Turning now to the detailed description of the disclosure, the figuresare described in some additional detail.

FIG. 1 shows the various surfaces of the teeth, and is helpful fororienting the reader to standard dental terminology. The facial, lingualand occlusal surfaces of the teeth are shown, and the tooth positioneris designed to contact all of these surfaces and apply a correctivepressure to one or more teeth. The names of individual teeth are omittedfrom this figure, but are standard in the art.

FIG. 2 shows a perspective view of the extra-oral vibratory device 110with tooth positioner 210. FIG. 3A and 3B more clearly illustrates thetooth positioner from two different angles. It is generally U-shaped, asis the dentition, and has a flat surface 220 that contacts the occlusalsurfaces of the teeth. Here, the tongue area is shown empty, but this isnot essential, and the central portion of the U-shape can also be filledin, provided the overall form is still comfortable. The generally flatsurface 220 also has labial/buccal (aka facial) and lingual edges onboth the upper and lower sides, which contact the labial and lingualsurfaces of the upper and lower dentition. More specifically, 230 is theupper labial edge, 240 is the lower labial edge, 250 is upper lingualedge and 260 is lower lingual edge. Also shown is socket 280 into whicha complementary stem 180 fits.

Note that the surfaces 220, 230, 240, 250, 260 are shown quite simply inFIG. 2-6, but in fact these surfaces will closely mimic tooth shape, butwith at least one area modified to apply a realignment pressure to thatarea. However, straight surfaces are shown for ease of illustration andunderstanding. FIG. 7 shows an aligner where the tooth shape is closelymimicked, and the bite plates of FIG. 2-6 will have a similar internalshape, and may also have a similar external shape for aesthetic andcomfort reasons.

FIG. 2 shows an extraoral housing, but if the electronics are simplifiedand/or miniaturized it would be possible to but the vibrator on theinside of the device, e.g., lingually, and such may be preferred as itwould minimize droolling, which tends to occur if the lips are heldopen, e.g., by an extraoral housing.

Another exemplary structure is illustrated in FIG. 4, which is a crosssection of the vibratory device 110 and half of a tooth positioner 210.The vibratory device 110 has a housing 105 containing all components,except the stem 180, which protrudes therefrom. Preferably, housing 105is water resistant or even more preferred it is waterproof orhermetically sealed. The housing contains battery 130, preferably arechargeable battery and can have an optional charging port (not shown).A source of vibration 140, which is preferably an offset motor orpiezoelectric motor is shown schematically as a simple box. Processor150 controls the vibratory source 140, and may also capture and storecompliance data. Data is transmitted to a server or computer or theinternet via data port or USB 160. Connections or wires 170 are shown insimple form only and not intended to convey actual wiring connections,as are on/off switches 120. Stem 180 is shown here with depressions 190,which can circumnavigate the stem in one embodiment, but many variationsof snap fitting and other connectors are possible. For example,cantilevered snap fits, cyclindical snap fits, and ball (spherical) snapfits are all possible, and can be combined with buttons for a reversablecoupling, or not, depending of the degree of material stiffness,coefficient of friction and lead and return angles.

Tooth positioner 210 can have a hard inner core that forms the socket205 and can be any suitable shape. A circle spring 290 fits intodepressions 190 on stem 180 and the tooth positioner thus removably snapfits onto the extraoral vibratory device. The tooth positioner has thelabial, lingual edges and occlusal surface as already described in FIG.3. Thus 220 is the flat surface which contacts occlusal surface of theteeth, edges 230 and 240 contact the facial tooth surfaces, while edges250 and 260 contact the lingual tooth surfaces. These various surfaces,220, 230, 240, 250 and 260 are shaped to closely follow a patient'steeth, but with adjustments made to pressure poorly aligned teeth into amore desirable position. Preferably, these edges are made of or at leastcoated with a resilient material of durometer at least 70 Shore A, mostpreferred is a biocompatible or medical grade clear silicone.

Similar devices are shown in FIG. 5, but in FIG. 5 stem 180 is fittedwith the holes 195 into which spring pins 295 fit. In FIG. 6, stem 180has a ridge or protrusion 196 that circumnavigates stem 180, and whichfits into a corresponding depression 296 in socket 205.

FIG. 7 shows an aligner combined with a vibrator. Only the lower jaw andlower teeth 1 are shown, above which is an transparent aligner 10. Anupper aligner is not shown herein, but usually the aligners are custommade for both upper and lower jaw. Aligner 10 is adapted to have a smallsocket 11 into which the removable vibrator can be fit. The removablevibratory device has a housing 21 enclosing a vibrator 22 and battery23. In this instance, due to size limitations, a peizeolectric vibrator22 may be preferred, together with a small coin battery 23.

Of course the socket and stem can be reversed, the aligner having astem, and the vibrator having a socket. Such may be preferred for verythin aligners, which may not allow entry of a stem without applyingpressure to the teeth. Alternatively, the socket can be built up fromthe surface of the aligner, thus not impinging the teeth. As yet anotheralternative, such attachment means can be eliminated and replaced e.g.,with adhesive or a magnetic mounting means.

We show herein a small vibratory device, but the vibratory device canalso mirror the shape of the aligner, fitting against the lingualsurface, optionally have more than one vibrator therein, and still snapfit into at least two sockets. It is also possible to permanently affixa vibrating component to the inner surface of the aligner, sincealigners are used for only a limited time, and then a new aligner isprovided. Thus, it is possible to make a low profile, watertightvibrator with sufficient battery life to last the life of the retainerthat is affixed to the aligner with snap fit mating parts or adhesivesor other methods. A patient accessible on/off switch will be required,e.g., a low profile depressible button, when the vibrating component isnot removable.

Housing 21 is watertight (hermetically sealed), such that the componentstherein do not get wet, and also has a smoothly curved, low profile soas to not overly interfere with tongue placement, and such. The housingmay also have a stem 24 projecting from it, that snap fits into hole 11.In preferred embodiments, the stem can also function as a depressibleon/off switch, such that inserting the device into hole 11simultaneously activates it, causing it to vibrate. If desired for costreasons, the processor can be omitted, and the vibrating componentinexpensively made such as to be disposable when the battery wears out.In other embodiments, the housing can have an access hatch for replacingthe battery.

The placement of hole or socket 11 can vary on the aligner 10, but isshown adjacent wisdom teeth here on the lingual side, although it canalso be placed on the facial side if the profile of the vibratorycomponent is sufficiently flat and the socket 11 back far enough (e.g.,positioned buccally and hidden by the cheek) so as the vibratorycomponent is not visible when the patient smiles. Hole 11 can beaccompanied by a matching hole on the other side. Alternatively, hole 11could also be placed near lip 2, but on the lingual side of the alignerso as to not mar the aesthetics of the aligner.

FIG. 8A shows the hinged positioner of U.S. Pat. No. 4,898,535, whereinpositioner 10 includes an upper trough 12 for receiving the maxillary orupper row of teeth, and a lower trough 14 for receiving the mandibularor lower row of teeth. The troughs are formed generally by alabial-buccal flange 16 and a lingual flange 18. The flanges areconnected by an isthmus portion 20. Both the upper and lower troughs areprovided with tooth receiving depressions or sockets 22, 24. Aconnecting hinge portion 34 is formed at a posterior end 36 of theappliance since the bite plate is slit only partially through theappliance thus leaving an anterior end 38 of the upper part 26 and ananterior end 40 of the lower part 30 separate from each other.

FIG. 8B shows a typical positioner contacting both upper and lowerarches, with three holes (arrow) shown for airway management. Such apositioner can easily be modified to accept one or more stems in theseholes, and if needed the holes lined with a stiffer material than therest of the positioner. Additional airway management perforations can beprovided if desired.

An aligner with pressure pockets, as described in US20110020761 is shownin FIG. 8C. The appliance 1900 is provided with one or more depressions1902, 1904, 1906, which can be any shape, and function to allow force tobe applied to corresponding raised surfaces that are adhered to teeth(see arrows). These raised areas allow the aligner to exert additionalforces at various angles depending on the position/shape of the raisedarea. The raised pressure buttons fit over the pockets, and allow themoving of difficult teeth, e.g., a force positioner can be applied to“twist” a rotated tooth into better alignment.

Although the systems and processes described herein have been describedin detail, it should be understood that various changes, substitutions,and alterations can be made without departing from the spirit and scopeof the invention as defined by the following claims. Those skilled inthe art may be able to study the preferred embodiments and identifyother ways to practice the invention that are not exactly as describedherein. It is the intent of the inventors that variations andequivalents of the invention are within the scope of the claims whilethe description, abstract and drawings are not to be used to limit thescope of the invention. The invention is specifically intended to be asbroad as the claims below and their equivalents.

Each of the following patents is incorporated by reference in itsentirety.

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1. An orthodontic remodeling device comprising: an extra-oral vibratorcomprising a waterproof housing containing a power source operablycoupled to a vibrator operably coupled to a processor for controllingsaid vibrator and for storing compliance usage data operably coupled toa data port for transmitting said data; said housing also having aconnector protruding therefrom; a tooth positioner shaped to fit apatient's dentition and apply a straightening force to at least one ofsaid patient's teeth, said tooth positioner being molded of a resilientmaterial that contacts labial, lingual and occlusal surfaces of saidpatients dentition, and having an inner rigid core shaped to accept saidconnector, such that said tooth positioner can be operably and removablycoupled to said extra-oral vibrator, said vibrator being able to vibrateat 1-1200 Hz at a force of 0.1-5 Newtons and thus vibrating said toothpositioner when coupled to said extra-oral vibrator.
 2. The orthodonticremodeling device of claim 1, said vibrator being able to vibrate at10-40 Hz.
 3. The orthodontic remodeling device of claim 1, said vibratorbeing able to vibrate at 0.1-0.5 Newtons.
 4. The orthodontic remodelingdevice of claim 1, wherein said power source is a rechargeable battery.5. The orthodontic remodeling device of claim 1, wherein said powersource is a rechargeable battery and said housing includes a chargingport.
 6. The orthodontic remodeling device of claim 1, wherein saidinner rigid core is metal.
 7. The orthodontic remodeling device of claim1, wherein said inner rigid core is a plastic of less than 40 Shore D.8. The orthodontic remodeling device of claim 1, wherein said resilientmaterial is medical grade silicone.
 9. The orthodontic remodeling deviceof claim 1, wherein said inner rigid core is a plastic of less than 40Shore D and said resilient material is medical grade heat cured siliconesubber.
 10. The orthodontic remodeling device of claim 1, wherein saidinner rigid core is a metal and said resilient material is medical gradesilicone.
 11. The orthodontic remodeling device of claim 1, said devicehaving a noise level less than 55 dB when measured at 6 inches, andbeing capable of vibrating at a frequency between 20-40 Hz with avariance of only 2 Hz, and a force between 0.1-0.5 Newtons with avariance of +−0.05 N.
 12. The orthodontic remodeling device of claim 1,said device having a noise level less than 55 dB when measured at 6inches, and being capable of vibrating at a frequency between 20-40 Hzwith a variance of only 2 Hz, and a force between 0.1-0.5 Newtons with avariance of +−0.05 N, wherein said inner rigid core is a plastic of lessthan 40 Shore D and said resilient material is medical grade silicone.13. The orthodontic remodeling device of claim 1, said device having anoise level less than 55 dB when measured at 6 inches, and being capableof vibrating at a frequency of 20-40 Hz, with a variance of only 2 Hz,and a force of 0.1-0.5 Newtons, with a variance of +−0.05 N, whereinsaid inner rigid core is metal and said resilient material is medicalgrade silicone.
 14. The orthodontic remodeling device of claim 11, saidvibrator being an offset motor with an 8 line integrated encoder. 15.The orthodontic remodeling device of claim 11, said vibratory sourcebeing a DC 6V motor having off-set weight and 8 line integrated encoder.16. An orthodontic remodeling device comprising: a tooth positionershaped to fit a patient's dentition and apply a straightening force toat least one of said patient's teeth, said tooth positioner contactinglabial, lingual and occlusal surfaces of said patient's dentition, saidtooth positioner operably connected to a housing enclosing a powersource operably connected to a vibratory source, said vibratory sourcebeing able to vibrate at 10-1200 Hz at a force of 0.1-5 Newtons and thusvibrating said tooth positioner.
 17. The orthodontic remodeling deviceof claim 16, said housing being reversibly connected to said toothpositioner.
 18. The orthodontic remodeling device of claim 16, saidhousing being affixed to said tooth positioner.
 19. The orthodonticremodeling device of claim 16, said housing further including an on/offswitch.
 20. The orthodontic remodeling device of claim 16, said housingbeing reversibly connected to said tooth positioner via a socket in saidtooth positioner and a connector on said housing shaped to fit saidsocket, said housing further comprising a depressible on/off switch thatfits into said socket and becomes activated thereon.
 21. An orthodonticremodeling device comprising: a tooth positioner being U-shaped andcontacting labial, lingual and occlusal surfaces of at least one arch ofa patient's teeth; said tooth positioner shaped to apply a straighteningforce to at least one of said patient's teeth; said tooth positionerbeing operably and reversably connected to a waterproof housingenclosing a power source operably connected to a vibratory source, saidvibratory source being able to vibrate at 20-40 Hz at a force of 0.1-2Newtons and thus vibrating said tooth positioner.
 22. The orthodonticremodeling device of claim 21, said housing being extraoral.
 23. Theorthodontic remodeling device of claim 21, said housing being intraoral.24. The orthodontic remodeling device of claim 23, said tooth positionercontacting both upper and lower arches of said patient's teeth.
 25. Theorthodontic remodeling device of claim 23, said tooth positioner beingprovided in separate upper part and lower part, said upper partcontacting an upper arch of said patients teeth, and said lower partcontacting a lower part of said patients teeth.
 26. The orthodonticremodeling device of claim 21, said postioner being coated with abiocompatible resilient polymer.
 27. A method of orthodontic remodelingcomprising using the device of claim 1 or 16 or 21 in a vibrating modefor at least 10 minutes a day.
 28. A method of orthodontic remodelingcomprising using the device of claim 1 or 16 or 21 in a vibrating modefor at least 10 minutes a day and using the tooth positioner alone in anon-vibrating mode at least overnight.